{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "Y",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OBT",
      "openfda": {
        "k_number": [
          "K182704",
          "K180624",
          "K110805",
          "K220190",
          "K093442",
          "K172183"
        ],
        "registration_number": [
          "3007125392",
          "3009631939",
          "1526534",
          "1834331",
          "3007539489",
          "9680825",
          "3014314623",
          "3013680140",
          "1824313",
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          "3007993775",
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          "3000327445",
          "3006783837",
          "3005061536"
        ],
        "fei_number": [
          "3007125392",
          "3009631939",
          "3009322142",
          "3002807395",
          "1526534",
          "3007539489",
          "3003414678",
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      },
      "review_panel": "OR",
      "medical_specialty": "OR",
      "device_name": "Plate, Bone, Growth Control, Pediatric, Epiphysiodesis",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Orthopedic",
      "device_class": "2",
      "definition": "Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis.  For gradually correcting angular deformities of long bones in pediatric patients with an open physis.  Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).  The device may be removed when growth has equalized or the growth plate has fused.",
      "regulation_number": "888.3030",
      "implant_flag": "Y",
      "submission_type_id": "1"
    }
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}